2013 OHSUG - Use Cases for using the Program Type View in Oracle Life Sciences Data Hub (LSH)

PREVIOUS NEXT PREVIOUS NEXT Oracle Health Sciences User group September 2013

Use Cases for using the

Program Type View

September, 2013

Mike Grossman Vice President of

Clinical Data Warehousing and

Analytics

BioPharm Systems

Welcome & Introductions

Mike Grossman Vice President of Clinical Data Warehousing and Analytics BioPharm Systems, Inc.

• CDW/CDA practice lead since 2010

– Expertise in managing data for all phases and styles of clinical trials

– Leads the team that implements, supports, enhances, and integrates Oracle’s LSH and other data warehousing and analytic solutions

• Extensive Oracle Life Sciences Hub (LSH) experience

– 10 years of experience designing and developing Oracle Life Sciences Hub at Oracle

– 27 years in the industry

– 5+ years of experiencing implementing LSH at client sites

Agenda

• What is a view program

• Use case 1 – Data pooling

• Use case 2 – Data security

• Use case 3 – Data blinding

What is a view program?

• An LSH program that has the “VIEW” technology type

• Allows you to combine data from multiple LSH table

instances without storing the data multiple times

• Creates a user-defined view of data across multiple table

instances

View Program

View Program Type

Table Descriptors

• Multiple LSH data sources

• A single target table

Source Code

SELECT [ hint ] [ { { DISTINCT | UNIQUE } | ALL } ] select_list FROM table_reference [, table_reference ]. . . [ where_clause ] [ hierarchical_query_clause ] [ group_by_clause ] [ HAVING condition ] [ model_clause ] [ { UNION [ ALL ] | INTERSECT | MINUS } ( subquery ) ] [ order_by_clause ]

Source Code

• Can only reference the program’s source table descriptors

• Can call functions/procedures which are included in

PL/SQL programs that are included as static references

• Cannot reference public database objects

View Table

• The view table is created

– When the view program is installed

– As a database view

• Can be used as a source table for other LSH programs,

data marts, or business areas

• The currency timestamp is applied every time you access

the view’s current data

• If you remove the view program instance the

corresponding table instance is also removed

View Data

From source DM

Data Currency

From source AE

Use Case 1 – Data Pooling

• The key to data pooling is having data that is standard, or

conformed

– SDTM or SDTM+

– Company standards

• Data can be pooled by

– Indication

– Therapeutic area

– Compound or device

– Etc.

• Pooled data can be used for

– On-going safety review

– Efficacy analysis

– To present the data to the sponsor in business area visualizations

– Etc.

• Data pooling can be

– Manual

– Automated

Manual Pooling

• Create the view program

• Add multiple table descriptors

• Launch the IDE to create and verify the source code

• Install the program

• Manually update the program

– When the source metadata changes

– To maintain the list of studies to be pooled

Automated Pooling

• Create and validate the pooling automation program

• Maintain the list of studies to be pooled

Automated Pooling

Tables to support the list of studies to be pooled,

metadata verification, etc.

Automated Pooling

Primary source code and shared PL/SQL

utilities

Automated Pooling

PL/SQL source code

Automated Pooling

Stores a list of LSH studies to include in the

automated pooling

Automated Pooling • The results in

View programs

View tables

Use Case 2 – Security • Use program views to limit a user’s access to only those

studies to which they’re authorized

• The DM_ALL dataset contains data for two studies but

the user should only have access to one of them

Security

• The view program

– Uses DM_ALL as the data source

– Generates the SECURITY_V table view

Security • The view program’s source code

– Restricts access at the study level

Security

• The results in a business area visualization

– Display only the study the user should be able to access

Use Case 3 – Data Blinding

• Views on tables to mask data

• Authorize feature

• Multiple views for blinded/dummy data

Contact Us

• North America Sales Contacts:

– Rod Roderick, VP of Sales, Trial Management Solutions

– rroderick@biopharm.com

– +1 877 654 0033

– Vicky Green, VP of Sales, Data Management Solutions

– vgreen@biopharm.com

– +1 877 654 0033

• Europe/Middle East/Africa Sales Contact:

– Rudolf Coetzee, Director of Business Development

– rcoetzee@biopharm.com

– +44 (0) 1865 910200

• General Inquiries:

– info@biopharm.com

2013 OHSUG - Use Cases for using the Program Type View in Oracle Life Sciences Data Hub (LSH)

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